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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceATS 3F AORTIC BIOPROSTHESIS MODEL 1000
Generic Nameheart-valve, non-allograft tissue
ApplicantMedtronic, Inc.
710 Medtronic Pkwy. NE
Minneapolis, MN 55432
PMA NumberP060025
Supplement NumberS003
Date Received01/05/2009
Decision Date03/05/2009
Withdrawal Date10/26/2016
Product Code LWR 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR EXTENSION OF THE SHELF-LIFE OF THE ATS 3F AORTIC BIOPROSTHESIS, MODEL 1000 VALVES (SIZES 19, 21, 23, 25, 27 AND 29 MM) FROM 2 YEARS TO 5 YEARS. THE DEVICE IS INDICATED FOR ¿..USE IN PATIENTS WHOSE AORTIC VALVULAR DISEASE IS SUFFICIENTLY ADVANCED TO WARRANT REPLACEMENT OF THEIR VALVE WITH A PROSTHETIC DEVICE. THE USUAL CONDITIONS OF ADVANCED DISEASE INCLUDE AORTIC STENOSIS, AORTIC INCOMPETENCE, AND A COMBINATION OF THE TWO.¿
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